VITROS 6801326
GUDID 10758750001101
VITROS Immunodiagnostic Products Anti-HCV Calibrator
ORTHO CLINICAL DIAGNOSTICS
Hepatitis C virus total antibody IVD, kit, chemiluminescent assay| Primary Device ID | 10758750001101 |
| NIH Device Record Key | 4edd1571-134e-4ae0-937c-cacda042d6c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VITROS |
| Version Model Number | 6801326 |
| Catalog Number | 6801326 |
| Company DUNS | 215865786 |
| Company Name | ORTHO CLINICAL DIAGNOSTICS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10758750001101 [Primary] |
| GS1 | 20758750001108 [Package] Package: Case [30 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P010021
FDA Product Code
| MZO | ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2014-10-22 |
On-Brand Devices [VITROS]
| 10758750002801 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack |
| 10758750002795 | VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack |
| 10758750002788 | VITROS Immunodiagnostic Products Anti-HBs Reagent Pack |
| 10758750002771 | VITROS Immunodiagnostic Products Anti-HBc Reagent Pack |
| 10758750002764 | VITROS Immunodiagnostic Products HBsAg Reagent Pack |
| 10758750001699 | VITROS Immunodiagnostic Products Anti-HBs Calibrator |
| 10758750001682 | VITROS Immunodiagnostic Products Anti-HBs Reagent Pack |
| 10758750001538 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrator |
| 10758750001521 | VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack |
| 10758750001453 | VITROS Immunodiagnostic Products HBeAg Calibrator |
| 10758750001446 | VITROS Immunodiagnostic Products HBeAg Reagent Pack |
| 10758750001439 | VITROS Immunodiagnostic Products Anti-HBe Calibrator |
| 10758750001422 | VITROS Immunodiagnostic Products Anti-HBe Reagent Pack |
| 10758750001224 | VITROS Immunodiagnostic Products Anti-HBc Calibrator |
| 10758750001217 | VITROS Immunodiagnostic Products Anti-HBc Reagent Pack |
| 10758750001194 | VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator |
| 10758750001187 | VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack |
| 10758750001101 | VITROS Immunodiagnostic Products Anti-HCV Calibrator |
| 10758750001095 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack |
| 10758750001088 | VITROS Immunodiagnostic Products HBsAg Confirmatory Kit |
| 10758750001071 | VITROS Immunodiagnostic Products HBsAg Calibrator |
| 10758750001064 | VITROS Immunodiagnostic Products HBsAg Reagent Pack |
| 10758750031597 | VITROS Immunodiagnostic Products HIV Combo Calibrator |
| 10758750031580 | VITROS Immunodiagnostic Products HIV Combo Reagent Pack |
| 10758750006267 | VITROS Immunodiagnostic Products Intact PTH Reagent Pack |
| 10758750006250 | VITROS Immunodiagnostic Products Intact PTH Calibrators |
| 10758750001309 | VITROS Immunodiagnostic Products PSA Reagent Pack |
| 10758750000319 | VITROS Immunodiagnostic Products PSA Calibrators |
| 10758750009077 | VITROS Immunodiagnostic Products Testosterone Reagent Pack |
| 10758750008902 | VITROS Immunodiagnostic Products LH Reagent Pack |
| 10758750006243 | VITROS Immunodiagnostic Products Intact PTH Range Verifier |
| 10758750006236 | VITROS Immunodiagnostic Products Intact PTH Controls |
| 10758750005017 | VITROS Immunodiagnostic Products Estradiol Reagent Pack |
| 10758750001156 | VITROS Immunodiagnostic Products Anti-HCV Controls |
| 10758750001149 | VITROS Immunodiagnostic Products HBsAg Controls |
| 10758750000845 | VITROS Immunodiagnostic Products Testosterone Range Verifiers |
| 10758750000814 | VITROS Immunodiagnostic Products Estradiol Range Verifiers |
| 10758750000777 | VITROS Immunodiagnostic Products Prolactin Range Verifiers |
| 10758750000760 | VITROS Immunodiagnostic Products FSH Range Verifiers |
| 10758750000753 | VITROS Immunodiagnostic Products LH Range Verifiers |
| 10758750000500 | VITROS Immunodiagnostic Products NTx Reagent Pack |
| 10758750000333 | VITROS Immunodiagnostic Products Progesterone Reagent Pack |
| 10758750000302 | VITROS Immunodiagnostic Products FSH Reagent Pack |
| 10758750000111 | VITROS Immunodiagnostic Products Prolactin Reagent Pack |
| 10758750009411 | VITROS Immunodiagnostic Products Anemia Controls |
| 10758750009053 | VITROS Immunodiagnostic Products Metabolism Controls |
| 10758750009015 | VITROS Immunodiagnostic Products Total Thyroid Controls |
| 10758750008803 | VITROS Immunodiagnostic Products Free Thyroid Controls |
| 10758750008322 | VITROS Immunodiagnostic Products RE Controls |
| 10758750002528 | VITROS Immunodiagnostic Products Troponin I ES Range Verifiers |
Trademark Results [VITROS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITROS 87764891 5492323 Live/Registered |
Crimson U.S. Assets LLC 2018-01-22 |
 VITROS 87202232 5204885 Live/Registered |
Crimson U.S. Assets LLC 2016-10-13 |
 VITROS 75142862 2126793 Live/Registered |
CRIMSON U.S. ASSETS LLC 1996-07-31 |
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